(Senior) PV Specialist, Affiliate Safety Representative

AbbVie.com

Office

Sofia, Bulgaria

Full Time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Primary Function:

Responsible to ensure that all aspects of Pharmacovigilance at the affiliate level meets AbbVie’s statutory and ethical responsibilities, and complies with local and regional PV regulations, for the applicable product portfolio.

Acts as the Affiliate’s lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PSEQ (Pharmacovigilance and Patient Safety, Epidemiology and Research & Development Quality Assurance) function.

Main Areas Of Responsibilities:

Metrics and Oversight of the Pharmacovigilance System
Quality Management System
Adverse Event & Periodic Safety Reporting
Audits and Inspections
Partnership with business partner with possibility for identification and/or handling of safety information
PV Training
Legislation Intelligence
Risk Management
Safety Monitoring
Launch Readiness
PV Advocacy
After Hours Availability & Business Continuity

Authority And Reporting Lines:

This position reports into the Affiliate Medical Director.

For all PV-related matters this position has additionally a dotted-line indirect reporting relationship to the EU QPPV

Qualifications

Medical, pharmacy or life-sciences degree (or equivalent).
At least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is required.
Excellent written and spoken communication and presentation skills.
Fluency in written and oral English is essential to facilitate communications with PSEQ, Area/Regional Medical and other headquarters functions
Fluency in written and oral local language a requirement to facilitate communications within the affiliate medical department, and with the National Regulatory Agency.
High customer orientation
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.

Additional Information

Critical Success Factors:

Builds and maintains strong relationships with affiliate colleagues.
Learns fast, grasps the “essence”, ability to manage complexity and changes to change course quickly where indicated to add value to the PV system.
Acts consistently with AbbVie’ s ethics, obligations and local laws – putting patient safety, partnerships and overall AbbVie’s interests before individual, immediate team and functional interests.
Focused on compliance; identifies, manages and escalates issues in a timely manner.
Strengthens the use of product safety knowledge and channels scientific safety evidence and benefit-risk information to area and affiliate stakeholders to positively impact business strategies.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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https://www.abbvie.com/join-us/reasonable-accommodations.html